FDA recall Z-1222-2020

Product

Terumo AZUR CX Peripheral Coil System, Detachable 18, CX Coil, REF numbers 45-781032, 45-781238, 45-781434, 45-781639, 45-781836, 45-782040, 45-780202, 45-780204, 45-780304, 45-780308, 45-780413, 45-780516, 45-780620, 45-780724, 45-780828, 45-780928, MV-AX80202CL, MV-AX80204CL, MV-AX80304CL, MV-AX80308CL, MV-AX80413CL, MV-AX80516CL, MV-AX80620CL, MV-AX80724CL, MV-AX80828CL, MV-AX80928CL, MV-AX81032CL, MV-AX81238CL, MV-AX81434CL, MV-AX81639CL, and MV-AX82040CL, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.

Reason for recall

The devices may be missing the implant coil.

Distribution

The devices were distributed to Maryland. There was no direct military/government distribution. Foreign distribution was made direct to Belgium, Japan, Australia, Argentina, and Mexico.

Key facts

Status

Terminated

Initiation date

2019-11-24

Report date

2020-02-19

Termination date

2021-04-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Aliso Viejo, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1222-2020